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Drugs: Licensing

Question for Department of Health

UIN 902127, tabled on 10 November 2015

To ask the Secretary of State for Health, what plans he has to improve the availability of off-patent drugs for novel uses through non-legislative measures.

Answered on

17 November 2015

Clinicians can already prescribe off-patent drugs off-label on clinical grounds if they judge this is the right thing to do to meet the individual clinical needs of their patients.


The Government is keen to accelerate the adoption of innovative medicines and increase the innovative use of existing medicines where the evidence reports clinical benefits and cost effectiveness to patients. To that end, we are seeking a number of initiatives to provide innovation but whilst supporting the aims of the Private Member’s Bill on this subject, we do not believe the proposed mechanism is either practicable and desirable.


We are working with NHS England, the National Institute for Health and Care Excellence, the General Medical Council and the Medicines and Health products Regulatory Agency to ensure that there is better information available to support clinicians who wish to prescribe off-patent drugs for off-label indications, and to ensure that new evidence is picked up more quickly and reliably and translated into clinical practice and can be fed through into licensing applications.


A huge amount of work is also going on in the Accelerated Access Review which will support the “pull” of innovation through to clinical practice.


As part of the debate on the Access to Medical Treatments Bill, we are working with officials in the Department, the Medicines and Healthcare products Regulatory Agency, and the Health and Social Care Information Centre to see how the power in the Bill, if it were to pass, could address the lack of provision of information on new uses for existing medicines via the power to create a database of innovations in order to support evidence-based prescribing.

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